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Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. The objective of this study is to assess a blood pressure monitoring system with an integrated algorithm that aids doctors in the decision-making process.
The SOT-ART-HT study is a single-center, randomized, open-label trial aimed at comparing two strategies for managing arterial hypertension. Patients in the control group will receive standard care, which includes regular visits to a hypertension clinic, while those in the intervention group will receive remote care through a specialized tele-informatic system designed to assist the physician. The trial will involve 200 participants, aged 18-80, with confirmed arterial hypertension and uncontrolled office blood pressure at the screening visit. Both primary and secondary outcomes will be evaluated, with the study expected to be completed after 2026. However, early termination could occur if required by regulatory bodies, an Ethics Committee, or the Scientific Research Committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Standard care involving regular visits to a hypertension clinic. Patients in the control group will receive standard care. They will have appointments according to the guidelines of the Polish Society of Hypertension -initially once a month and, after achieving control (i.e., blood pressure in office measurement < 140/90 mmHg), once every 3 months. | |
| Study group | Experimental | In the intervention group, a care model using a system implementing an algorithm that supports therapeutic and diagnostic decisions made by the doctor in the care of patients with AH will be applied. The algorithm identifies patients who have or have not achieved therapeutic goals and suggests actions for specific patients, but the final therapeutic and diagnostic decisions are always made by the doctor. It is emphasized that the treating physician is not bound by the algorithm's recommendations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process | Other | Receiving remote care facilitated by a specialized informatic system to support the physician |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Achieving Arterial Blood Pressure Control | Time from study initiation to the day of achieving arterial blood pressure control, defined as a 7-day mean of home blood pressure measurements below 135/85 mmHg | After completing the presumed six-month follow-up of the last participant |
| Assessment of Achieving Arterial Blood Pressure control at 6 months | The time from study initiation to 6 months of participation, achieving arterial blood pressure control, defined as a 7-day average of home blood pressure measurements below 135/85 mmHg | After 6 months of participating |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements | Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements | Baseline up to approximately six-months of observation |
| Assessment of the number of the medical visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paweł Uruski, MD PhD | Contact | (+48) 618546274 | puruski@ump.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences | Recruiting | Poznan | 60-848 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40890870 | Derived | Lipski D, Lewandowska K, Zurek S, Wisniewicz M, Pirog P, Tykarski A, Uruski P. Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions-study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial. Trials. 2025 Sep 1;26(1):330. doi: 10.1186/s13063-025-09044-w. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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The number of medical visits from study initiation to completion |
| After completing the presumed six-month follow-up of the last participant |
| Assessment of the maintaining blood pressure control | Total time maintaining blood pressure control, defined as the number of days with a 7-day mean of home measurements below 135/85 mmHg | After completing the presumed six-month follow-up of the last participant |
| Assessment of the cost of visits | Cost of visits incurred by the medical institution and the patient | After completing the presumed six-month follow-up of the last participant |